Alabama Supreme Court Rules Makers of Brand-Name Medications Can Be Held Liable For Warnings On Generic Drugs

The Alabama Supreme Court recently upheld its decision in Wyeth v. Weeks, holding that brand-name drug manufacturers can be held liable for injuries caused by their generic counterparts. The decision is great news for Alabamians who have been harmed by ingesting generic drugs, but who have been unable to attain a judicial remedy due to federal regulations governing the ability of generic drug manufacturers to unilaterally strengthen their own warning labels. The ruling is clearly a victory for consumers, but it’s very limited in application.

There has been some unjustified criticism of the Court, coming primarily from uniformed sources. The Wall Street Journal editorial board jumped on the bandwagon, calling the Supreme Court ruling “dubious” and saying it set a dangerous precedent against innovation. That’s totally false and educated folks should know better. This Alabama Supreme Court decision is important because it finally makes a theory of liability available to these plaintiffs who have no other means of redress for the harm they suffer.

The ruling come from a certified question sent to the Court by a federal judge in a lawsuit filed by Danny and Vick Weeks against five current and former drug makers alleging that long-term use of the heartburn drug metoclopramide, which was also sold under the brand name Reglan, caused a debilitating movement disorder known as tardive dyskinesia. The safety labels on the generic drugs failed to warn of potential side effects, including the risk of tardive dyskinesia.

Justice Michael Bolin wrote the main opinion, saying it is not unfair for the maker of a brand-name drug to be liable for warnings on generic counterparts, because generic drug companies by law must use the same safety labels as their brand-name counterparts. Justice Bolin notes the ruling applies only to a specific set of facts involving a medication that is subject to a lot of heavy federal regulation.

Lew Garrison and Chris Hood, lawyers with the Birmingham firm Heninger Garrison Davis, represented the plaintiffs in this case. They have done a very good job. If you need more information about the general subject matter, contact Danielle Mason, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.